CN109620845A - A kind of pearl nasal drops and preparation method thereof for treating allergic rhinitis - Google Patents
A kind of pearl nasal drops and preparation method thereof for treating allergic rhinitis Download PDFInfo
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
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Abstract
The invention discloses a kind of pearl nasal drops for treating allergic rhinitis and its facture, this method is mixed by raw materials such as pearl powder, water, sodium carbonate, and irradiated sterilizing is made, and has the function of Reduce allergy rhinitis.The production method is simple, and materials safety is reliable, and manufactured pearl nasal drops Reduce allergy rhinitis significant effect, persistent is without side-effects, can be used for a long time.
Description
Technical field
The invention belongs to pharmaceutical technology field, it is related to a kind of pearl nasal drops and preparation method thereof, is specifically related to one kind and controls
Treat the pearl nasal drops and preparation method thereof of allergic rhinitis.
Background technique
Pearl is to secrete nacre by pearl shell, and alien material is constantly wrapped up in layers, forms pearl long.Pearl
Main component be calcium carbonate, also containing magnesium, iron, zinc, manganese, cobalt, many human body beneficial elements of chromium and amino acid, taurine,
Organic principles such as chitin etc..Pharmacopoeia of the People's Republic of China version in 2015 is recorded, pearl: it is fixed that [function and cure mainly] calms the nerves
Frightened, improving eyesight disappears screen, solves taking poison and growing muscle due, moistening skin and eliminating spot.For insomnia of palpitating with fear, infantile convulsion epilepsy, cataract, sore do not held back, skin-color
Spot.
Allergic rhinitis is to be discharged, simultaneously after atopic individuals contact sensibiligen by the medium (mainly histamine) that IgE is mediated
There are many schneiderian membrance chronic inflammatory reaction diseases of the participations such as immunocompetent cell and cell factor, with rhiocnesmus, sneeze, nose point
Secreting hyperfunction, schneiderian membrance swelling etc. is main feature.Allergic rhinitis hinders breathing, is easy to make one anoxic, especially sleep therebetween,
Influence it is very big, often make patient because anoxic has difficulty in going to sleep or midnight suppressed it is awake.Anoxic is also easy to cause a series of cardiovascular and cerebrovasculars
Disease.
Doctor trained in Western medicine often uses antihistaminic medicine, Patients Treated with Steroid allergic rhinitis.Antihistamine drug easily causes drowsiness
Side effect, amcinonide of short duration can only more use, and it is big that side effect is used for a long time.
Common nasal drops or nasal wash are normal saline solution in the market, or slightly adjusted based on concentration of physiological saline
Sodium chloride solution.Although can use its salt concentration height, thus it is possible to vary inflammatory cell osmotic pressure, to mitigate inflammation, for a long time
Using without side-effects, but action time is short, is easy to be watered down and failed by nasal secretion, is suitable for mild rhinitis, if long-term use
The sodium chloride solution of high concentration can have certain stimulation to nasal cavity.
The effective component of pearl powder can be such that capillary permeability reduces, and play an important role to the formation of antibody;Pearl
Powder is in alkalescent in water, plays the role of preferably diminishing inflammation.Pearl main component is biological aragonite, accounts for about 90%, biology text
Stone is skeleton ingredient, thus safe to the human body reliable.
Pearl quality is hard, is slowly dissolved in water, solubility very little.The thinner pearl powder the easy to release in water
The ingredient of pearl, is absorbed by the body;Pearl powder of the average grain diameter less than 1 micron is easier to firmly be adhered on nasal cavity, is not easy to take off
It falls.Pearl powder and water mixing are easy uniformly to be applied on nasal cavity, not will form bulky grain within the scope of certain mixed proportion
Object will not fall off under nasal cavity moistening environment, even if falling off, be sucked into lung, because pearl is harmless absorbable ingredient,
Soakage is also very small, will not have adverse effect to human body.Pearl powder and water mixing, are easy to adherency condensation, no after dry
It will form dust, therefore even if falling off in nasal cavity, be also not easy to be sucked into lung.Unabsorbed pearl powder can be by nose in nasal cavity
Secretion adherency in chamber, is excreted;Nasal cavity cleaning can also be smeared with the cotton swab that gets wet daily fall pearl powder residue.
Novelty of the invention:
A kind of pearl nasal drops for treating allergic rhinitis of the method for the present invention production is solid-liquid suspension, is free of preservative,
Uniform adhesion is easy on nasal cavity, forms a thin layer of medicine layer;Pearl powder is under solid-liquid suspension state, slow release
The effective component of pearl out, these effective components play an important role to nasal cavity inflammation, the aeration status for improving nasal cavity is alleviated;Solution
In alkalescent, be conducive to mitigate inflammation;It is non-stimulated to nasal cavity, action temperature and, be used for a long time it is without side-effects.For different degrees of
Allergic rhinitis has remission effect, especially serious allergic rhinitis.Using irradiation sterilization, the effective of pearl can be both kept
Activity, and be not easy putrid and deteriorated.Pearl nasal drops of the invention is pearl powder and water, sodium carbonate mixing, with this condition, water
In alkalescent (pH is greater than 10.5), most microorganisms are difficult to survive solution, avoid the use of preservative.
Pearl nasal drops made of the present invention is solid-liquid suspension, easy to use, is dipped with cotton swab and gos deep into nasal cavity smearing i.e.
It can;Affected part is directly acted on, efficiently, directly, survival dose is few, avoids caused pain of having an injection for effect.When inflammation occurs, directly
Nasal cavity is acted on, symptom is alleviated;A kind of pearl nasal drops for treating allergic rhinitis of this method production, effect are better than market
Upper common physiological saline nasal drops, nasal wash.Nasal drops, nasal wash based on physiological saline, only with its height
Penetration theory mitigates cellular inflammation, and physiological saline is easy to be diluted by nasal secretions, shortens physiological saline action time.
Pearl nasal drops made of the present invention plays the role of that nasal secretion is inhibited excessively to secrete, and keeps drug ingedient effect more longlasting.
Pearl nasal drops made of the present invention is solid-liquid suspension, and pearl composition is slowly dissolved in water, when use pearl at
Divide and can be done directly on affected part, works rapidly, can take effect in several minutes to half an hour.
Summary of the invention
The purpose of the present invention is provide a kind of pearl nasal drops for treating allergic rhinitis in view of the deficiencies of the prior art
And preparation method thereof, it can treat the symptom of allergic rhinitis, inhibit the secretion of nasal secretion, obtain nostril aeration status
To improvement, improvement is significantly better than currently used physiological saline nasal drops, physiological saline nasal wash.One kind of the invention is controlled
The pearl nasal drops for treating allergic rhinitis is using pearl powder, water, sodium carbonate as primary raw material, through made of mixing, irradiation sterilization
Solid-liquid suspension can be suppressed growth of microorganism without adding preservative using its aqueous solution meta-alkalescence, avoid being used for a long time anti-
Rotten agent causes adverse consequences to nasal cavity.The pearl nasal drops of this method production can improve patient nostril ventilation shape by persistent high efficiency rapidly
Condition is suitable for anaphylaxis severe patient, or with the bad patient of physiological saline remission effect.
The technical scheme adopted by the invention is that:
Raw material is calculated in parts by weight, comprising: pearl powder 1-70 parts by weight, water 30-99 parts by weight, sodium carbonate 0.1-15 parts by weight.
Preferably, a kind of pearl nasal drops for treating allergic rhinitis, raw material are calculated in parts by weight, comprising: pearl powder 25-
60 parts by weight, water 40-75 parts by weight, sodium carbonate 0.5-3 parts by weight.Wherein the partial size d50 of pearl powder is 0.01-0.5 microns,
D90 is less than 2 microns;Water is clean water;Sodium carbonate is food-grade or pharmaceutical grade.
The present invention also provides a kind of pearl collunarium liquor manufacture methods for treating allergic rhinitis, comprising steps of
Pearl powder and water are weighed by weight, and sodium carbonate is put into blender and is stirred until homogeneous, and temperature is room temperature, is packed into medicinal bottle
Then the sealing of the containers such as son saves.
The present invention also provides a kind of pearl collunarium liquor manufacture methods for treating allergic rhinitis, it is preferable that comprising steps of
Pearl powder and water are weighed by weight, and sodium carbonate is put into blender and is stirred until homogeneous, and temperature is room temperature.It is packed into bottle on demand
The sealing of the containers such as son, then irradiation sterilization, radiation absorber amount are 5-9KGy, obtain the sterile solid-liquid of pearl powder and water, sodium carbonate
Suspended matter,.
A kind of pearl nasal drops for treating allergic rhinitis provided by the invention, application method are preferred are as follows: with before shaking up, use
Cotton swab picks suspension and probes into nostril depths smearing nasal cavity, and each nostril is smeared 1-3 times, smeared 1-3 times daily.Pearl used
The thinner powder the better, and thinner pearl powder is easier by nasal absorption, and antianaphylaxis is stronger.In general, pearl powder used is flat
Equal partial size should be especially preferred with average grain diameter less than 0.5 micron less than 1 micron.
A kind of pearl nasal drops and preparation method thereof for treating allergic rhinitis provided by the present invention.This is technically simple,
Calcium in pearl powder plays the role of Reduce allergy, and aqueous solution is in alkalescent, does not generate stimulation to nasal cavity, can also inhibit scorching
Disease even is eliminated nasal cavity inflammation state to mitigate.Pearl powder can be absorbed by the body, and unabsorbed pearl powder can be with
Nasal secretion excretes.
Specific embodiment
Using embodiment, the invention will be further described below.Additional aspect and advantage of the invention will be retouched in following
It states middle part to give out, partially will become apparent from the description below, or practice through the invention is recognized.
A kind of production method of pearl nasal drops for treating allergic rhinitis provided by the present invention is: pearl powder 1-70 weight
Part, water 30-99 parts by weight are measured, sodium carbonate 0.1-15 parts by weight are uniformly mixed, then bottle, cover bottle cap sealing, 1-15KGy
Dose delivery sterilizing,.
Embodiment 1
Pearl powder 3.5kg is taken, 1g sample is taken to detect through 2000 laser particle analyzer of Malvern, d50 is 0.35 micron, d90 0.93
Micron;Take clean water 6.4kg;Take sodium carbonate 0.1kg.Pearl powder and clean water, sodium carbonate are uniformly mixed in mixing machine, stirred
Mix speed 30r/min.After stirring 25min, start to bottle.It bottles in whipping process, avoids precipitating.Take the medicinal plastics of 100ml
1000, bottle fills 983 bottles per bottled 100g altogether.Bottle cap is tightened, then irradiation sterilization, irradiation dose 6.1KGy.
Validity check
As shown in the following table 1,2.Severe allergic patients with rhinitis 20 are selected, symptom is severe nasal blockage, is had a running nose.It is divided into 2 groups, one
The pearl nasal drops of 10 people's the present embodiment of group is first firmly shaken up with preceding, the pearl collunarium of the present embodiment is then picked with cotton swab
Liquid gos deep into nostril as far as possible and smears nasal cavity, and each nasal cavity is smeared 2 times, picks about 0.3g every time, is then experienced in 0.5h, 3h, 6h
Ventilatory conditions.Nostril state of feeling after: ventilation alleviation degree is divided into 5 grades, and a is absolutely not to alleviate, without effect;
B is slightly to alleviate, effective to ventilating;C is that have half alleviation;D is that have more than half alleviation, and ventilation is slightly blocked, and e is completely slow
Solution, ventilation are normal.Meanwhile another group of 10 people use common physiological saline nasal wash as Contrast on effect, dip physiology with cotton swab
Salt water nasal wash 0.3g, gos deep into nasal cavity smearing as far as possible, and each nostril is smeared 2 times.
(patient indicates 1 first group of physiological saline nasal wash using effect of table statistics with digital number, aeration status grade
It is indicated with lowercase)
Patient | The nostril 0.5h state | The nostril 3h state | The nostril 6h state |
1 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
2 | C, nasal cavity moisten | C restores to have a running nose | A, nasal cavity swelling, secretion are more |
3 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
4 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
5 | C, nasal cavity moisten | C restores to have a running nose | A, nasal cavity swelling, secretion are more |
6 | C, nasal cavity moisten | C restores to have a running nose | A, nasal cavity swelling, secretion are more |
7 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
8 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
9 | C, nasal cavity moisten | C restores to have a running nose | A, nasal cavity swelling, secretion are more |
10 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
From the experimental results, with having certain effect in 3 hours after physiological saline nasal wash, full recovery is to using after 6 hours
State before physiological saline.
(patient indicates the pearl nasal drops using effect statistics of 2 second groups of the present embodiment of table with digital number, shape of ventilating
State grade is indicated with lowercase)
Patient | The nostril 0.5h state | The nostril 3h state | The nostril 6h state |
11 | E, nasal cavity moisten | E, no secretion | E, no secretion |
12 | E, nasal cavity moisten | E, no secretion | E, no secretion |
13 | E, nasal cavity moisten | E, no secretion | D, no secretion |
14 | E, nasal cavity moisten | E, no secretion | E, no secretion |
15 | E, nasal cavity moisten | E, no secretion | E, no secretion |
16 | E, nasal cavity moisten | E, no secretion | C, no secretion |
17 | E, nasal cavity moisten | E, no secretion | D, no secretion |
18 | E, nasal cavity moisten | E, no secretion | E, no secretion |
19 | D, nasal cavity moisten | D, no secretion | D, no secretion |
20 | E, nasal cavity moisten | E, no secretion | E, no secretion |
Using the pearl nasal drops of the present embodiment, 6h still maintains relatively good nasal airflow effect, and effect is far super common raw
Manage salt water nasal wash.2 times a day, using the pearl nasal drops of the present embodiment one week, there are 8 humans allergic's Rhinitis Symptoms in this 10 people
It disappears, is not recurred in hereafter January;Remaining 2 people continue to use 1 month, and 2 people's symptoms disappear, and do not recur in hereafter January;After half a year
It is abnormal caused by this 10 people nasal cavity is checked without the pearl nasal drops because using the present embodiment.Using physiological saline nasal wash one week,
No one allergic rhinitis symptoms disappear in this 10 people, continue to use one month, this 10 humans allergic Rhinitis Symptoms does not disappear yet.
Micro biological Tests
The present embodiment bottled sealing pearl nasal drops place 12 months, have no swollen bottle phenomenon;It 10 bottles of random inspection, opens
It watches, it is no abnormal.
The pearl nasal drops of the present embodiment that bottle cap uses is opened, close the lid sealing in time after, is stored at room temperature, by daily
It using 3 frequencies, is watched after 1 month, the pearl nasal drops appearance of the present embodiment, color and smell are without exception.By GB
Method as defined in 4789.2-2016 detects total plate count, as a result less than 10/g.
Embodiment 2
Pearl powder 4.0kg is taken, 1g sample is taken, is detected through 2000 laser particle analyzer of Malvern, partial size d50 is 1.6 microns, and d90 is
4.1 micron;Take clean water 5.6kg;Take sodium carbonate 0.4kg.By pearl powder and clean water, sodium carbonate mixes in mixing machine
It is even, mixing speed 30r/min.After stirring 25min, in whipping process, 100ml plastic drug package 1000 are taken, per bottled
100g fills 983 bottles altogether.Bottle cap is tightened, then irradiation sterilization, irradiation dose 6.1KGy.
Validity check
As shown in the following table 3,4.Severe allergic patients with rhinitis 20 are selected, symptom is severe nasal blockage, is had a running nose.It is divided into 2 groups, one
The group pearl nasal drops of the present embodiment gos deep into nostril with the pearl nasal drops that cotton swab picks the present embodiment as far as possible and smears nose
Chamber, each nasal cavity are smeared 2 times, pick about 0.3g every time, then experience ventilatory conditions in 0.5h, 3h, 6h, and the nostril after is felt
State: ventilation alleviation degree is divided into 5 grades, and a is absolutely not to alleviate, without effect;B is slightly to alleviate, effective to ventilating
Fruit;C is that have half alleviation;D is that have more than half alleviation, and ventilation is slightly blocked;E is complete incidence graph, and ventilation is normal.Meanwhile another group
It uses common physiological saline nasal wash as Contrast on effect, dips physiological saline 0.3g with cotton swab, go deep into nasal cavity smearing as far as possible,
It smears 2 times in each nostril.
(patient indicates 3 third group physiological saline nasal wash using effect of table statistics with digital number, aeration status grade
It is indicated with lowercase)
Patient | The nostril 0.5h state | The nostril 3h state | The nostril 6h state |
21 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
22 | C, nasal cavity moisten | C, secretion are few | A, nasal cavity swelling, secretion are more |
23 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
24 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
25 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
26 | C, nasal cavity moisten | C, secretion are few | A, nasal cavity swelling, secretion are more |
27 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
28 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
29 | C, nasal cavity moisten | B restores to have a running nose | A, nasal cavity swelling, secretion are more |
30 | C, nasal cavity moisten | C, secretion are few | A, nasal cavity swelling, secretion are more |
From the experimental results, with having certain effect in 3 hours after physiological saline nasal wash, full recovery is to using after 6 hours
State before salt water.
(patient indicates the pearl nasal drops using effect statistics of the 4th group of the present embodiment of table 4 with digital number, shape of ventilating
State grade is indicated with lowercase)
Patient | The nostril 0.5h state | The nostril 3h state | The nostril 6h state |
31 | E, nasal cavity moisten | E, no secretion | E, no secretion |
32 | E, nasal cavity moisten | E, no secretion | E, no secretion |
33 | E, nasal cavity moisten | E, no secretion | D, a small amount of secretion |
34 | E, nasal cavity moisten | E, no secretion | E, no secretion |
35 | E, nasal cavity moisten | E, no secretion | E, no secretion |
36 | E, nasal cavity moisten | E, no secretion | C, a small amount of secretion |
37 | E, nasal cavity moisten | E, no secretion | D, a small amount of secretion |
38 | E, nasal cavity moisten | E, no secretion | E, no secretion |
39 | D, nasal cavity moisten | D, no secretion | D, a small amount of secretion |
40 | E, nasal cavity moisten | E, no secretion | E, no secretion |
Using the pearl nasal drops of the present embodiment, 6h still maintains relatively good nasal airflow effect, and effect is far super common raw
Manage salt water nasal wash.By 2 times a day, using the present embodiment pearl nasal drops one week, there is the disappearance of 6 people's symptoms in this 10 people, hereafter 1
It is not recurred in month;Remaining 4 people continue to use 1 month, and 4 people's symptoms disappear, and do not recur in hereafter January.Deactivated up till now 10 people are monthly
Check nasal cavity, without the pearl nasal drops because using the present embodiment caused by it is abnormal;Check this 10 people after deactivating half a year, nasal cavity without
It is abnormal caused by pearl nasal drops because using the present embodiment.Using physiological saline nasal wash one week, no one's mistake in this 10 people
Quick property Rhinitis Symptoms disappear, and continue to use one month, this 10 humans allergic Rhinitis Symptoms does not disappear yet.
Micro biological Tests
The present embodiment bottled sealing pearl nasal drops place 12 months, have no swollen bottle phenomenon;It 10 bottles of random inspection, opens
It watches, it is no abnormal.
The pearl nasal drops of the present embodiment that bottle cap uses is opened, close the lid sealing in time after, is stored at room temperature, by daily
It using 3 frequencies, is watched after 1 month, the pearl nasal drops appearance of the present embodiment, color and smell are without exception.By GB
Method as defined in 4789.2-2016 detects total plate count, as a result less than 10/g.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, without departing from the technical principles of the invention, several improvements and modifications can also be made, these improvements and modifications
Also it should be regarded as protection scope of the present invention.
Claims (4)
1. a kind of pearl nasal drops for treating allergic rhinitis, which is characterized in that raw material presses component by weight, comprising: pearl
Powder 1-70 parts by weight, water 30-99 parts by weight, sodium carbonate 0.02-15 parts by weight.
2. a kind of pearl nasal drops for treating allergic rhinitis, production method feature exists according to requirement described in patent right 1
In: pearl powder and water, sodium carbonate are mixed, stirred evenly, mixing speed 1-100000r/min.
3. a kind of pearl nasal drops for treating allergic rhinitis, production method feature exists according to requirement described in patent right 2
In: the mixture bottling stirred evenly, after sealing, irradiation sterilization, radiation absorber amount 1-15KGy.
4. according to requirement described in patent right 1,2, a kind of pearl nasal drops for treating allergic rhinitis, it is characterised in that: used
Oxide spinel sodium can also with potassium carbonate, saleratus, sodium hydroxide, potassium hydroxide, triethanolamine substitution.
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2019
- 2019-02-20 CN CN201910127482.XA patent/CN109620845A/en active Pending
Non-Patent Citations (3)
Title |
---|
徐元贞等: "《新全实用药物手册》", 28 February 2005, 河南科学技术出版社 * |
施杞等: "《现代中医药应用与研究大系 第十三卷 五官科》", 30 September 1998 * |
王竹鑫等: "《袖珍中药炮制速查手册》", 30 September 2013, 湖南科学技术出版社 * |
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